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ASLN Slumps As TreeTopp Flops, CSTL On Watch, KDMN Rocks, NXTC Down 53%

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Today's Daily Dose brings you news about the disappointing TreeTopp trial results of ASLAN Pharma; better-than-expected financial results of Castle Biosciences; positive topline results from Kadmon's planned interim analysis of its ROCKstar trial; updated results from NextCure's phase I/II trial with NC318.

Read on…

ASLAN Pharmaceuticals' (ASLN) pivotal study of Varlitinib in second-line biliary tract cancer, dubbed TreeTopp, has failed to meet the primary endpoints of progression-free survival and overall response rate.

The Company is now focusing on ASLAN004, which is under a phase I multiple ascending dose study is in patients who have moderate-severe atopic dermatitis. Interim readout from this study is expected in early 2020.

ASLN closed Monday's trading at $0.66, down 67.98%.

Castle Biosciences Inc. (CSTL), a skin cancer diagnostics company, has reported strong third-quarter financial results, driven by solid growth in its DecisionDx-Melanoma test report volume.

Net income for the third quarter of 2019 was $5.54 million or $0.05 per share compared to a net loss of $4.46 million or $2.33 per share in the year-ago quarter. Net revenue surged to $14.77 million in the recent third quarter from $3.71 million in the third quarter of 2018. Analysts polled by Thomson Reuters were expecting a loss of $0.30 per share and revenue of $9.45 million for the third quarter of 2019.

During the third quarter of 2019, the Company delivered 4,126 DecisionDx-Melanoma test reports and 356 DecisionDx-UM test reports. This compared with 3,136 DecisionDx-Melanoma test reports and 324 DecisionDx-UM test reports in the third quarter of 2018.

The Company went public on the Nasdaq Global Market on July 25, 2019, offering its shares at a price of $16 each.

CSTL has thus far hit a low of $15.26 and a high of $28.50. The stock closed Monday's trading at $21.81, down 1.22%.

Shares of Kadmon Holdings Inc. (KDMN) were up over 20% in extended trading on Monday, following positive topline results from the planned interim analysis of its ROCKstar trial.

ROCKstar is a pivotal, open-label clinical trial of KD025 in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy.

The trial met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, with KD025 showing statistically significant ORR of 64% at 200 mg once daily, and an ORR of 67% at 200 mg twice daily.

An open-label registration trial of KD025 in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy, dubbed KD025-213, is underway. The primary analysis of the KD025-213 study, which will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life, will occur in the first quarter of 2020.

KDMN closed Monday's trading at $2.99, down 0.66%. In after-hours, the stock was up 20.74% to $3.61.

The FDA has once again refused to approve Lipocine Inc.'s (LPCN) TLANDO, an oral testosterone product candidate, for testosterone replacement therapy in adult males for hypogonadism.

The regulatory agency has cited the failure of the efficacy trial to meet the three secondary endpoints for maximal testosterone concentrations ("Cmax") as the reason for denying approval to TLANDO.

This is the third time that TLANDO has been sent back to the drawing board.

LPCN closed Monday's trading at $0.80, down 70.70%.

MyoKardia Inc.'s (MYOK) phase II clinical trial of Mavacamten in patients with non-obstructive hypertrophic cardiomyopathy, dubbed MAVERICK-HCM, has achieved its primary objective of safety and tolerability in the patients. Despite the positive results, the stock lost over 7% of its value as the rate of adverse events was greater in the Mavacamten groups than the placebo group.

Although the majority of adverse events reported were mild or moderate in severity and reversible or self-resolving, transient ejection fraction reductions below the protocol-defined threshold of 45% occurred in five participants in the active drug arms.

Based on the safety and pharmacologic benefits observed in the MAVERICK study, MyoKardia plans to advance Mavacamten into additional studies in defined groups of patients with non-obstructive HCM and heart failure with preserved ejection fraction (HFpEF).

A phase III trial evaluating Mavacamten in treating patients with obstructive hypertrophic cardiomyopathy, dubbed EXPLORER-HCM, is underway, with topline data expected in the second quarter of 2020.

MYOK closed Monday's trading at $55.45, down 7.60%.

NextCure Inc. (NXTC) slumped more than 50% on Monday because investors were not impressed by the updated clinical results from the Phase 1 portion of its ongoing phase I/II trial with NC318 in advanced or metastatic solid tumors, which includes ovarian cancer, non-small cell lung cancer, or NSCLC, and head and neck squamous cell carcinoma.

Initial results from the phase I portion of phase I/II trial of NC318 in advanced or metastatic solid tumors, published in an abstract, were released on November 6, 2019, which sent the Company's stock soaring to over 300% that day. The initial data were from 43 patients dosed across 6 dose cohorts (8mg - 800mg Q2W).

The abstract released on November 6, 2019, revealed that single-agent activity was seen in NSCLC including one complete response (ongoing at 41 weeks), one partial response (ongoing at 14 weeks), 1 stable disease with tumor reduction (ongoing for 26 weeks), and 2 with stable disease.

The updated data reported on Monday were from 49 patients dosed across seven dose cohorts between 8 mg and 1,600 mg, administered every two weeks.

As per the new data, the Company noted that durable responses were observed in patients who received NC318, including one complete response (ongoing at 55 weeks), one partial response (ongoing at 28 weeks) and four stable diseases in NSCLC (ongoing for 16 to 40 weeks) and 14 stable diseases overall (ongoing for 16 to 42 weeks).

The Company has initiated the phase II portion of its ongoing phase I/II trial of NC318. Initial data from the Phase 2 portion of the trial is expected by the end of 2020.

NXTC closed Monday's trading at $39.02, down 52.93%.

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